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J. Garde



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    P1.24 - Poster Session 1 - Clinical Care (ID 146)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P1.24-020 - Efficacy and safety of carboplatin and pemetrexed for the first line treatment of unfit patients to receive cisplatin with nonsquamous non small cell lung cancer (ID 1563)

      09:30 - 16:30  |  Author(s): J. Garde

      • Abstract

      Background
      Background: Pemetrexed activity is synergistic with both carboplatin and cisplatin in chemonaive NSCLC patients. Two phase II Pem plus carboplatin trials have confirmed the doublet’s activity in NSCLC and response rates were 31% and 24% (Scagliotti and al 2003, Zinner and al 2005). Carboplatin is a good alternative in unfit patients suggesting a balanced benefit/risk profile when combined with Pem.

      Methods
      Sixty-four patients unfit to receive cisplatin with measurable stage III-B IV NSCLC, received at least one dose of chemotherapy. Pem 500 mg/m2 over 10 min on day 1 with folic acid and vitamin B12 supplementation followed by carboplatin AUC 5 on the same day were given every 21 days for 4- 6 cycles. Primary endpoint was safety and efficacy ( progression free survival)

      Results
      Sixty four patients received at least one dose of chemotherapy. Median age was: 71.3 yrs (86−44,3), 90,6% of patients presented comorbilities , mainly cardiopathy (73,4%) . Stages IIIb: 15,6%, IV: 84,4%. Non squamous cell carcinoma: 100.% (adenocarcinoma: 92,2%, large cell carcinoma: 7.8% )Male 76,6%, female 23,4%. The median number of administered cycles was 4. Median progresion free survival and overall survival will be presented at the meeting. Grade 3/4 toxicities related to study drugs were: asthenia 6.1%, skin 3.1%, dyspnea 3.1% .Hematological grade 3/4 events were: neutropenia: 6.1%, thrombocytopenia: 1,6%, anemia: 14.1%. 10,9% of patients need dose reduction

      Conclusion
      In first line NSCLC, the combination of Pem plus carboplatin could be a valuable treatment alternative in unfit patients to recive cisplatin. Anemia is the most frequent toxicity in this combination.

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    P3.06 - Poster Session 3 - Prognostic and Predictive Biomarkers (ID 178)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P3.06-035 - Study of the correlations between SNPs in angiogenic genes and treatment response/ outcome in patients with advanced NSCLC (non-squamous histology) treated in first line with carboplatin, paclitaxel and bevacizumab (CPB). The ANGIOMET study. (ID 2664)

      09:30 - 16:30  |  Author(s): J. Garde

      • Abstract

      Background
      It has been demonstrated that the addition of bevacizumab to paclitaxel plus carboplatin (CPB) in the treatment of advanced NSCLC improves survival. Even though, there is a high variability in drug efficacy between patients, leading to different response rates. ANGIOMET is an exploratory study promoted by the SLCG in advanced NSCLC, non-squamous histologies (NS-NSCLC) treated in first line with a combination scheme based in CPB, designed to investigate the relationship between angiogenic mediators and the outcome and response to treatment. The primary end-point was progression-free survival (PFS), and the secondary end-points are the follows: OS, response-rates and toxicity profiles.

      Methods
      In this multicentric study, patients with stage IIIB/IV NS-NSCLC (ECOG status 0–2) were included and treated in first line with CPB. Peripheral blood samples were collected before treatment administration and DNA was purified from the leukocyte fraction. Ten SNPs of VEGF-pathway genes were genotyped in 186 samples by RT-PCR in duplicate. SNPs were related to PFS and OS (Kaplan-Meir method, log-rank test) and to response rate.

      Results
      10 SNPs were determined in 186 DNA samples. In this preliminary analysis there were data from 108 patients valid for PFS and OS analysis. Baseline characteristics of the patients were: median age, 63 years [37-80]; 74.5% male; 94.1% ECOG PS 0-1; 14% never-smokers, 100% caucasian; 89.7% adenocarcinomas, 2.8% large cell carcinomas; median number of CPB cycles was 4. There was no response assessment in 27 patients (25%), 30.6% PR, 31.5% SD and 13.0% PD. The SNP rs833061 (CC) in VEGFA correlated with lower response rates to CPB than the other genotypes (p=0.07). SNPs in KRAS and VEGFR2 were associated with PFS and/or OS in our cohort. The KRAS SNP rs10842513 (TT+CT) was associated with shorter PFS compared with the CC genotype (median: 5.39 vs 6.81 months; p=0.04, respectively). The VEGFR2 SNP rs2071559 (AA) was significantly associated with longer PFS and OS (Table 1). No significant differences in PFS or OS were observed according to other SNPs analyzed. Table 1: PFS and OS for VEGFR2 SNPrs2071559.

      PFS
      % Median (months) 95%CI p
      VEGFR2 (rs2071559)
      AA 25.6 9,408 5,084 - 13,732 0.01
      GG+AG 74.0 5,724 4,902 - 6,546
      OS
      % Median (months) 95%CI p
      VEGFR2 (rs2071559)
      AA 25.6 NR ---- 0.001
      GG+AG 74.0 12,270 8,760 – 15.780

      Conclusion
      These preliminary data indicate that genetic variation in VEGFR2, SNP rs2071559 variant AA, is associated with prognosis in advanced NS-NSCLC patients treated with CPB and may have predictive implications as biomarkers in patients treated with chemotherapy with bevacizumab. On behalf of the Spanish Lung Cancer Group (SLCG)